A trial of vinflunine for cancer of the penis (VinCaP)

Cancer type:

Penile cancer




Phase 2

This trial is looking at the chemotherapy drug vinflunine for penile cancer that has spread outside the penis, or to another part of the body. The trial is supported by Cancer Research UK.

More about this trial

Doctors often treat cancer of the penis with surgery. But if the cancer has spread outside the penis or to other parts of the body, it may not be possible to remove it completely with surgery. In this situation you may have chemotherapy.

In this trial, researchers are looking at a chemotherapy drug called vinflunine. The aims of the study are to see

  • If vinflunine works as well as other types of chemotherapy
  • Whether it causes fewer side effects

Who can enter

You may be able to enter this trial if

  • You have a type of penile cancer called squamous cell cancer
  • Your cancer has grown into surrounding tissue or lymph nodes Open a glossary item, or has spread to another part of your body
  • Your cancer can’t be removed with surgery
  • Your cancer can be measured on a scan, or if the only area of cancer that can be measured is on your skin, it must be at least 10mm across
  • You have satisfactory blood test results
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Your liver works well enough (the trial team can advise you about this)
  • You are at least 18 years old
  • You are willing to use reliable contraception during the trial and for a year afterwards if there is any chance your partner could become pregnant

You cannot enter this trial if you

  • Have a rare type of penile cancer called verrucous carcinoma (your doctor can advise you about this)
  • Have cancer that started in the tube that carries urine through the penis (your urethra Open a glossary item)
  • Aren’t well enough to have vinflunine, or can’t have chemotherapy for some reason
  • Have already had radiotherapy to all areas of cancer spread
  • Have already had chemotherapy or a combination of chemotherapy and radiotherapy
  • Have had any other cancer that needed treatment in the last 2 years apart from non melanoma skin cancer

Trial design

This phase 2 trial aims to recruit 22 men in the UK. Everybody taking part will have vinflunine.

You have vinflunine through a drip into a vein every 3 weeks. It takes about an hour each time.

Each 3 week period is called a cycle of treatment. You start by having 4 cycles of treatment.

If the treatment is helping, and you and your doctor feel that you are well enough, you may have more than 4 cycles of treatment. If you do, you carry on having the treatment in the same way for as long as it helps you.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

You go to hospital every 3 weeks to see the trial team and have chemotherapy. You have regular blood tests.

You have a CT scan after the 4th cycle of treatment (so about 3 months after your treatment started). You may also need to have another MRI scan.

If you continue having vinflunine for longer than the first 4 cycles of treatment, you will have a CT scan every 12 weeks.

When you finish chemotherapy, you see the trial team again after 3 months, 6 months, 9 months, 1 year, 18 months and 2 years.

Side effects

As vinflunine is quite a new chemotherapy drug, there may be long term side effects we don’t know about yet. The known side effects include



Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Lisa Pickering
Dr Steve Nicholson

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
Pierre Fabre Ltd UK

Other information

This is Cancer Research UK trial number CRUK/12/021.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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